Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 3, 2023
Open Peer Review Period: Aug 2, 2023 - Sep 27, 2023
Date Accepted: Jul 8, 2024
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
A Research Protocol for Developing and Validating the PERSONAE Scale: Assessing Preparedness for Self-Management of Oral Anticoagulation in Adult Patients
ABSTRACT
Background:
Optimal anticoagulation using vitamin K antagonists (VKAs) like warfarin can effectively prevent strokes associated with atrial fibrillation and heart valve replacements. Self-monitoring and self-management of anticoagulation using point-of-care testing equipment (POCT) have shown promise in improving patient outcomes. However, understanding the factors influencing the preparedness of individuals for self-testing is essential for effective implementation.
Objective:
This research protocol aims to outline the methodology for developing and validating the PERSONAE scale, a self-report measure designed to assess the preparedness for self-monitoring and self-management of oral anticoagulation in adult patients. Additionally, the study seeks to identify preferred technology-assisted learning options for potential use in future educational interventions.
Methods:
This multiphase study comprises two main phases. Phase one involves conceptualizing the PERSONAE scale through a literature review, a consensus meeting among developers, and obtaining face and content validity through an expert panel. Phase two comprises validation procedures, including cross-sectional data collection, followed by Mokken scaling analysis (MSA) to identify relevant items for the scale. A confirmatory factor analysis (CFA) will cross-validate the scale’s unidimensional structure in a second data collection round.
Results:
The PERSONAE scale will be developed and validated based on a sample of Italian adult patients on long-term oral anticoagulation. The psychometric properties, including reliability and validity measures, will be presented. Preliminary levels of preparedness for self-monitoring and self-management will be reported. Additionally, preferred technology-assisted learning options among patients will be identified.
Conclusions:
The PERSONAE scale will be a valuable tool to assess patients’ preparedness for self-monitoring and self-management of oral anticoagulation. The study’s insights into technology-assisted learning preferences will inform the design of future educational interventions to enhance preparedness in adult patients. Clinical Trial: ClinicalTrials.gov NCT05973240
Citation
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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.